Risk Management Standard Update Published Within Days For EU MDR Use
Executive Summary
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.
You may also be interested in...
Go-Ahead For Appointment Of European Union Reference Labs For IVDs
EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.
How Europe’s Nomenclature System Works And Offers New Insights
Transparency linked to new device registration rules will provide new market analysis possibilities. Medtech Insight delved deeper into the benefits of the European Medical Device Nomenclature with two Italian executives who see its potential.
Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.